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Phase II Clinical Trial of TROGLITAZONE, a Ligand for the Peroxisome Proliferator-Activated Receptor Gamma (PPAR), as Antineoplastic Differentiation Therapy for Patients With Malignant Liposarcoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Sarcoma

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Trial Information

Phase II Clinical Trial of TROGLITAZONE, a Ligand for the Peroxisome Proliferator-Activated Receptor Gamma (PPAR), as Antineoplastic Differentiation Therapy for Patients With Malignant Liposarcoma


OBJECTIVES: I. Evaluate the clinical activity of troglitazone in patients with malignant
liposarcoma. II. Evaluate the tolerance and safety of troglitazone in this patient
population.

OUTLINE: This is an open label trial. All patients are given a single dose of oral
troglitazone daily. Patients continue to receive troglitazone as long as their disease
responds to treatment or remains stable.

PROJECTED ACCRUAL: Initially, 14 patients of each of the 5 subtypes of liposarcoma will be
accrued. If 1 or more patients show evidence of biological response, an additional 16
patients of each subtype will be accrued for a total of 30 per subtype.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven liposarcoma that is incurable by standard
surgery Measurable or evaluable disease required No active CNS involvement or
leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT less than 5 times
upper normal limit Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No poorly
controlled atrial arrhythmias, angina pectoris, or myocardial infarction within past 6
months No symptomatic congestive heart failure, percutaneous transluminal coronary
angioplasty, or coronary artery bypass graft within past 3 months Other: Not pregnant or
nursing Fertile patients must use effective contraception No known active retroviral
disease

PRIOR CONCURRENT THERAPY: Recovered from toxic effects of all prior therapy No concurrent
cytotoxic therapy Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed
Endocrine therapy: No concurrent hormonal therapy Radiotherapy: Prior radiation therapy
for metastatic disease allowed No radiotherapy to sole site of measurable disease within
past 6 months Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

George D. Demetri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000065717

NCT ID:

NCT00003058

Start Date:

June 1997

Completion Date:

Related Keywords:

  • Sarcoma
  • adult liposarcoma
  • recurrent adult soft tissue sarcoma
  • Liposarcoma
  • Sarcoma

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115